Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID
NCT07416188
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Brain Cancer
  • Brain and Central Nervous System Tumors
  • GBM
  • Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
  • Glioblastoma Multiforme
  • Glioblastomas
  • Glioma
  • Glioma, Malignant
  • Grade IV Astrocytoma
  • High Grade Glioma
  • Recurrent Glioblastoma
  • Recurrent Glioma (Glioblastoma Multiforme)
  • Recurrent Tumor
  • Recurring Glioblastoma
  • Relapsed Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • LMP744 — DRUG
    Indenoisoquinolone C-MYC/TOPOISOMERASE 1 Inhibitor
  • Conventional Surgery or Biopsy — PROCEDURE
    Conventional Surgery or Biopsy

Study Details

Background: Glioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells. Objective: To test LMP744 in people with glioblastoma. Eligibility: People aged 18 years or older with glioblastoma that returned after treatment. Design: Participants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function. Participants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein. LMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time. Participants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery. Participants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits. Participants will continue to have telehealth visits every 3 months after they stop taking the drug.

Key Dates

Start date
Jun 16, 2026
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    All patients will receive LMP744 as the interventional drug along with surgery for a biopsy and a second surgery for either resection or an additional biopsy to compare the tissue pre vs. post-drug treatment.

Primary Outcome Measure

Partial response (>=50% disease reduction) or complete response (100% disease reduction) based on RANO 2.0 criteria [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222
Surgical Neurology Branch
[email protected]
(301) 496-2921

Find similar trials in Bethesda, MD

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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